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LEADING THE NEWS
CMS Issues Long-Awaited Proposed Rule on ACOs
On March 31, CMS proposed new rules under the health-care reform law intended to help doctors, hospitals and other health-care providers better coordinate care for Medicare patients through accountable care organizations (ACOs). Under CMS’ proposal, ACOs would create incentives for health-care providers to work together to treat an individual patient across care settings, including doctor’s offices, hospitals and long-term care facilities. ACOs would be rewarded by achieving lower growth in health-care costs while meeting performance standards on quality of care and putting patients first. Patient and provider participation in an ACO is purely voluntary.
There will be a 60-day public comment period on the proposed ACO rule. AGA will submit detailed comments on issues of importance to the practice of gastroenterology prior to the June 6 deadline.
AGA is reviewing the complete rule and will provide a more detailed analysis in AGA eDigest and the AGA Washington Insider.
Proposed Rule Highlights
Under the proposed model, an ACO would have a physician-directed quality assurance and process improvement committee that would oversee an ongoing quality assurance and improvement program. The quality assurance program would establish internal performance standards for quality of care and services, cost effectiveness, and process and outcome improvements, and hold ACO providers/suppliers accountable for meeting the performance standards.
An ACO would also develop and implement evidence-based medical practice or clinical guidelines and processes for delivering care consistent with the goals of better care for individuals, better health for populations and lower growth in expenditures. The guidelines and care delivery processes would cover diagnoses with significant potential for the ACO to achieve quality and cost improvements — taking into account the circumstances of the individual beneficiary — and could be accomplished, for example, through an integrated electronic health record with clinical decision support. ACO participants and ACO providers/suppliers would have to agree to comply with these guidelines and processes and to be subject to performance evaluations and potential remedial actions.
ACOs are one of a number of new payment models proposed under the health-care reform law that could have a significant impact on the practice of medicine, in general, and specialists, in particular.
POLICY
Negotiations Continue on Budget Deal
An agreement to fund the remainder of the current fiscal year remains elusive as both Democrats and Republicans went public with their frustration with the negotiations this week. Democrats were blaming the tea party wing of the Republican Party for refusing to negotiate, and stated that the problem with the Republicans was internal. However, Republican leaders were quick to strike back, stating that the Democrats had not offered any credible alternative to H.R. 1, which would cut $61 billion in non-defense discretionary spending this year.
Democrats in the Senate rejected H.R. 1 and subsequently, two temporary continuing resolutions (CRs) have been passed that have cut $10 billion in government programs. However, Vice President Biden stated that both sides have agreed to spending cuts of $33 billion in the 2011 budget, but have not ironed out the details. Although Republicans have disputed this, they do agree that negotiations are ongoing.
Republican leaders are under pressure from their conservative members to not only stay firm on the House-passed cuts, but also to ensure that an agreement contains the policy riders that eliminate funding from Planned Parenthood, defund the health-care reform law and prevent the Environmental Protection Agency from implementing regulations on carbon emissions. Republican leaders may agree to lesser cuts if these policy riders are included, but it is unclear whether enough Democrats would agree to these policies to pass an agreement.
The current CR expires on April 8, and if both sides do not reach an agreement, the government will shut down, which both sides want to avoid.
AGA continues to monitor these negotiations and advocates against deep cuts to the NIH. We will continue to provide updates on the budget process in the AGA Washington Insider and AGA e-Digest.
NEWS FROM THE LITERATURE
Are CRC Screening Recommendations Too Aggressive?
Consensus guidelines of the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer and the American College of Radiology recommend that first-degree relatives of individuals diagnosed with an adenoma before age 60 should be screened every five years with colonoscopy starting at age 40. This is the identical recommendation for those with a first-degree relative diagnosed with colorectal cancer before age 60. In a review appearing in Clinical Gastroenterology and Hepatology, doctors stated that, given the weakness of evidence supporting the guidelines, suboptimal levels of screening in the general population and lack of resources to comply with the recommendation, first-degree relatives of individuals with adenomas should be screened as average-risk persons until more compelling data are available to justify more aggressive screening.
Clinical Gastroenterology and Hepatology 2011: 9(4): 308-13
Dextranomer Injection Effective for Fecal Incontinence
Injection of a bulking agent in the anal canal is an increasingly used treatment for fecal incontinence, but efficacy has not been shown in a controlled trial. According to data published in The Lancet, a refinement of selection criteria for patients, optimum injected dose, ideal site of injection and long-term results might further increase the acceptance of this minimally invasive treatment.
The Lancet 2011: 377(9770): 997-1003
Most Children with Potential Celiac Disease Remain Healthy
The presence of celiac disease-associated auto-antibodies (anti-endomysium and anti-tissue transglutaminase [anti-TG2]) with normal jejunal mucosa indicate potential celiac disease. Study results in Clinical Gastroenterology and Hepatology suggest that most children with potential celiac disease remain healthy. After three years, approximately 33 percent of patients develop villous atrophy. Intestinal deposits of anti-TG2 IgA identify children at risk for villous atrophy.
Clinical Gastroenterology and Hepatology 2011: 9(4): 320-325
Gastric Cancer Can Arise from Subclone of Founder Mutation
Studies of the clonal architecture of gastric glands with intestinal metaplasia are important in our understanding of the progression from metaplasia to dysplasia. It is not clear if dysplasias are derived from intestinal metaplasia or how dysplasias expand. There is evidence for a distinct clonal evolution from metaplasia to dysplasia in the human stomach, suggest doctors in a study published in Gastroenterology. By field cancerization, a single clone can expand to form an entire dysplastic lesion. Over time, this field appears to become genetically diverse, indicating that gastric cancer can arise from a subclone of the founder mutation.
Gastroenterology 2011: 140(4): 1251-1260.e6
PRACTICE
Are the Needs of GERD Patients Being Met?
Nearly 19 million Americans are affected by GERD, with patients reporting an occurrence of heartburn two or more days a week despite treatment and variation in diet.
On Friday, April 1, 2011, from 1 to 2 p.m. ET, join Prateek Sharma, MD, an associate professor of medicine in gastroenterology and hepatology, University of Kansas School of Medicine, during an interactive webinar that will provide insight on the impact of GERD and persistent heartburn in patients affected by these conditions.
Dr. Sharma will share results and reveal findings from the new, nationwide DISCUSS (Defining and Identifying GapS in CommUnication Between GERD/Heartburn SuffererS and PhysicianS) survey, which was developed in partnership with Takeda Pharmaceuticals North America, Inc. Highlights include the importance of productive interaction between patients and their health-care providers about the symptoms and triggers of GERD and/or frequent heartburn.
Register for the webinar.
RESEARCH
Your AGA Research Foundation Gifts Support ...
... Tien Dong, BS, of the University of Chicago, who received the AGA Research Foundation Student Abstract Prize in 2010.
“As an undergraduate, I went through my four years exploring mostly clinical research without much basic science research exposure. When I entered medical school, I made the choice to explore basic science research in a field that interests me — cancer development. I have known many people who have fought against cancer, and so, that is why I have made it my goal to learn more about it. My current research is exploring the roles of short-chain fatty acids on colon cancer through their interactions with microRNAs. We hope to elucidate the mechanism of the protective role that fiber may play in cancer development. My long-term goal is to have research incorporated with my clinical career. This award means a lot to me because it represents my first steps in that direction. Even though this may have been my first experience with basic science research, the current progress in my work, along with this award, motivate me to make sure that it will not be my last.”
To make a donation, visit www.gastro.org/contribute.
AGA Research Foundation Honors Donor VIPs
AGA Research Foundation donors are VIPs to the hundreds of young GI researchers who have received foundation support over the years.
During DDW®, almost 100 members of the AGA Legacy Society will be honored at the benefactors dinner in the Signature Room on the 95th floor atop of the John Hancock Building in Chicago. Legacy Society members are individuals and couples who have pledged to support the AGA Research Awards Program though generous gifts and bequests.
During the past 27 years, more than $40 million has been distributed by the AGA to more than 600 outstanding awardees. The AGA Research Scholar Award (RSA) provides critical funding to investigators as they establish their research careers and apply for long-term grants from the NIH and other major funding agencies. In a recent survey, 92 percent of RSA recipients reported that they remained in academic GI research careers.
Individuals who make Legacy Society pledges before DDW will be invited to the benefactors dinner. For information about the foundation and the Legacy Society, please visit www.gastro.org/aga-foundation.
| Council Elections Open |
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The AGA Institute Council is now holding elections for seven new vice chairs and nominating committee members. Voting will end on April 15, 2011. Learn More |
EDUCATION & MEETINGS
UC Virtual Clinic Helps Improve Patient Care
The Ulcerative Colitis (UC) Virtual Clinic is a two-part, interactive, case-based activity that follows a virtual UC patient through two office visits. Designed to improve clinical outcomes and enhance quality of life for UC patients, this activity examines guideline-recommended approaches to the management of recurrent or refractory UC, with emphasis on first- and second-line pharmacologic therapies and the factors that affect adherence to treatment regimens.
- Patient visit one: a 34-year-old woman with onset of bloody diarrhea in established UC.
- Patient visit two: a 34-year-old woman with refractory UC.
Each visit is a CME-accredited activity (0.05 AMA PRA Category 1 credit). This activity is supported by an educational grant from Centocor Ortho Biotech Services, Inc. and Abbott Laboratories.
Earn CME with Digestive Disease Week® 2010 Webcasts
Free CME-certified webcasts of the most popular sessions from DDW® 2010 are now available to AGA members, providing on-demand, online access to dozens of sessions covering a range of topics.
The regularly scheduled webcasts, which will be released bi-weekly, are grouped by area of practice focus and research interest.
This week’s webcasts focus on esophageal, gastric and duodenal disorders:
• Evaluation and Treatment of PPI Non-Responders.
• New Drugs for GERD.
• Once on a PPI, Always on a PPI?
• Adverse Effects of Long-Term GERD Therapy — Fact or Fiction.
To view the webcasts, visit the AGA Institute’s CME resource library.
| Train the Trainers Program |
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Apply now for this exciting program that will bring two educators to Porto Alegre, Brazil, Aug. 11–16, to develop their teaching and training skills. Learn More |
ANNOUNCEMENTS
Fracture Risk with Short-Term, Low-Dose PPIs Unlikely
FDA has determined an osteoporosis and fracture warning on the over-the-counter (OTC) PPI medication drug facts label is not indicated at this time. Following a thorough review of available safety data, FDA has concluded that fracture risk with short-term, low-dose PPI use is unlikely.
The available data show that patients at highest risk for fractures received high doses of prescription PPIs (higher than OTC PPI doses) and/or used a PPI for one year or more.
In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14-day course of treatment up to three times per year. FDA acknowledges that consumers, either on their own or based on a health-care professional’s recommendation, may take these products for periods of time that exceed the directions on the OTC label. Health-care professionals should be aware of the risk for fracture if they are recommending use of OTC PPIs at higher doses or for longer periods of time than in the OTC PPI label.
Adverse Reactions Caused by Melanoma Treatment
Bristol-Myers Squibb, in collaboration with the FDA, developed a risk evaluation and mitigation strategy (REMS), which is required to ensure that the benefits of YERVOY™ (prescription medicine used in adults to treat melanoma that has spread or cannot be removed by surgery) outweigh the risks of severe and fatal immune-mediated adverse reactions.
In order for Bristol-Myers Squibb to communicate certain risks about YERVOY, Bristol-Myers Squibb has worked with the FDA to develop materials to communicate the risks of severe and fatal:
- Immune-mediated enterocolitis (including gastrointestinal perforation).
- Immune-mediated hepatitis (including hepatic failure).
- Immune-mediated dermatitis (including toxic epidermal necrolysis).
- Immune-mediated neuropathies.
- Immune-mediated endocrinopathies.
Full prescribing information and REMS materials are available at www.YERVOY.com/hcp/rems.
JOURNALS & PUBLICATIONS
Call for Papers on Clinical Trials: Gastroenterology
Gastroenterology is committed to advancing clinical practice in the field of digestive disease. Recognizing that clinical trials generally have the greatest impact of all studies on clinical practice, Editor Anil K. Rustgi, MD, and his associate editors strongly encourage authors to submit their manuscripts on clinical trials (diagnostic validation, therapeutic efficacy) of drugs, biological materials and devices in digestive, liver and pancreatic diseases, including studies at Phases I, II and especially III, to Gastroenterology for consideration. The journal is also interested in publishing trials in endoscopic and imaging modalities.
There are several important reasons to submit clinical trial research for publication in Gastroenterology:
- With an impact factor of 12.9, Gastroenterology is the premier journal in the field.
- Gastroenterology is the journal that will directly reach the largest portion of physicians who care for and make treatment decisions for patients with GI or liver disease.
- Authors who submit their manuscripts to Gastroenterology typically will receive decisions within three weeks or fewer.
- Accepted manuscripts will be published online and indexed on PubMed within 10 days of acceptance.
To submit your manuscript to Gastroenterology, go to www.editorialmanager.com/gastro.
For important information on how to report clinical trials, go to www.gastrojournal.org/authorinfo. To review the current and past issues of the journal, go to www.gastrojournal.org.
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